Medart Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Medart Corp. makes
Medart Corp. manufactures laser-based medical systems, including diode and CO₂ laser platforms for surgical applications, as well as a cooling system for tissue protection during procedures. Their product line covers the UNI-LASER series (models 425P, 430, 450P, and 470) and the MEDART 520 Cooling System, designed for precision and versatility in clinical settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their portfolio is authorised for commercial distribution in the United States, where Medart Corp. is based.
Catalogue
Medart 520 Cooling System Ref K000503
Regimes: 510(k) Registry: 510(k)Uni-Laser 430 Ref K993815
Regimes: 510(k) Registry: 510(k)Uni-Laser 470 Ref K010885
Regimes: 510(k) Registry: 510(k)Uni-Laser 425P Diode Laser System & Accessories Ref K991659
Regimes: 510(k) Registry: 510(k)Uni-Laser 450P CO2 Laser System & Accessories Ref K991297
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medart Corp. have in the registry?
The registry currently lists 5 devices for Medart Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medart Corp.'s devices?
Among its 5 most recently registered devices, Medart Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Medart Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Medart Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medart Corp. in the registry?
The most recently registered devices listed for Medart Corp. include MEDART 520 COOLING SYSTEM, UNI-LASER 430, UNI-LASER 470 and UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES.